USA – The US Food and Drug Administration (FDA) has bestowed breakthrough device designation upon AlphaMedix (lead-212-Dotamtate), a targeted alpha therapy developed by RadioMedix and Orano Med, currently undergoing Phase II trials for a rare type of neuroendocrine tumor.  

This marks the first FDA breakthrough designation for a targeted alpha therapy, according to a press release issued on February 12. 

Targeted alpha therapy employs the emission of alpha particles, helium nuclei, which coupled with high linear energy transfer, effectively destroy tumor cells by inducing DNA double-strand breaks.  

By attaching these alpha particle-emitting radioisotopes to tumor-selective carrier molecules, cancer cells are specifically targeted, sparing healthy cells from harm. 

AlphaMedix utilizes a somatostatin receptor (SSTR)-targeting peptide complex radiolabeled with lead-212.  

The FDA’s designation was predicated on findings from both a Phase I trial (NCT03466216) and an ongoing Phase II trial (NCT05153772), which investigate the therapy’s efficacy in patients with unresectable or metastatic, progressive gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) expressing SSTR. 

An estimated 12,000 patients are diagnosed with neuroendocrine tumors annually in the US, with a 60% average survival rate after five years at the metastatic stage, as per RadioMedix and Orano Med. 

Preliminary data from the Phase I trial showcased a 62.5% response rate among GEP-NET patients who had not previously received Novartis’ peptide receptor radionuclide therapy (PRRT) Lutathera.  

Encouragingly, the target response rate has already been attained in the Phase II trial, which concluded patient enrollment in May 2023. Topline data from this trial is expected in mid-2024. 

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Ebrahim Delpassand, CEO of RadioMedix said he had confidence that AlphaMedix could offer significant advantages over existing PRRT therapies. 

AlphaMedix faces stiff competition   

 However, AlphaMedix faces stiff competition from Novartis’ Lutathera, which witnessed a 34% sales surge in the first nine months of 2023, reaching US$458 million. 

 Lutathera, approved by the FDA in 2018, ranked among Novartis’ top 20 best-selling products in 2023. 

Additionally, Exelixis and Ipsen have made strides in the neuroendocrine tumor domain with their tyrosine kinase inhibitor candidate Cabometyx (cabozantinib), reporting positive Phase III trial results in October 2023, with an FDA application anticipated in 2024. 

With forecasts indicating the neuroendocrine tumor market to reach US$3.42 billion by 2030 across eight major markets, Novartis is anticipated to dominate half of the market with its portfolio, which includes the older therapy octreotide, marketed as Sandostatin. 

Julien Dodet, CEO of Orano Med, expressed optimism, stating, “We are convinced that targeted alpha therapies, such as AlphaMedix, will lead the next generation of radioligand therapies.” 

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